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Medical Devices / Regulatory Affairs / Research and Development

IVD Devices: FDA Drafts Guidances on Clinical Trials, Replacing Reagents

Jan. 4, 2018

The FDA issued draft guidance on the use of investigational in vitro diagnostic devices in therapeutic product clinical trials, and a separate guidance for updates on IVD replacement reagents.

According to the agency, the growing interest in personalized medicine, otherwise known as precision medicine, called for the policy clarifications.

Personalized medicine relies on the use of IVDs to detect and measure biomarkers and other individual characteristics of diseases or other conditions with the goal of better directing patient treatment.

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